Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting

The University of Texas System (UT)

Status: Unknown

Conditions: Growth Failure; Malnutrition; Nutrition; Nutrition Disorder, Infant; Malnutrition in Medically Complex Infants; Nutrition in Medically Complex Infants; Growth Failure in Medically Complex Infants

Treatments: Behavioral: Usual Care; Behavioral: Standardized Medical Nutrition Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03522558

HSC-MS-18-0276

Details and patient eligibility

About

The purpose of this study is to compare standardized nutrition therapy provided by a registered dietitian (RD) at regularly scheduled intervals to usual care in terms of the ability to improve growth parameters in medically complex infants in the pediatric outpatient setting.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 2 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients who are admitted between July, 2018 and June, 2019 to the Neonatal High-Risk Clinic (NHRC) and High Risk Children's Clinic (HRCC) at UT Health from a neonatal intensive care unit (NICU)

Exclusion criteria

• short bowel syndrome,
• requiring parenteral nutrition (PN)
• active cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Standardized Medical Nutrition Therapy

Experimental group

Description:

Standardized Medical Nutrition Therapy will include nutrition assessment provided by a registered dietitian (RD) at initial clinic visit or first Well Child Check (WCC) and regularly scheduled nutrition follow-up at each WCC visit thereafter.

Treatment:

Behavioral: Standardized Medical Nutrition Therapy

Usual Care

Active Comparator group

Description:

At the primary care provider's discretion, a nutrition consult can be requested for the RD to perform nutrition assessment or discuss the patient's plan without full nutrition assessment, as is current practice. Currently in the Neonatal High-Risk Clinic (NHRC) and High Risk Children's Clinic (HRCC) at UTHealth, providers consult the RD as deemed appropriate with no established criteria for when to include the RD in patient care. Usual care will not be modified by the study protocol.

Treatment:

Behavioral: Usual Care